JP2002520088A - Apparatus and method for treating heart disease - Google Patents

Abstract

SUMMARY A jacket formed of a biocompatible material has an interior volume sized for insertion of the apex and sliding the jacket over the heart. The jacket has a longitudinal dimension between the upper and lower ends sufficient to surround the lower heart, surrounds the annulus of the heart, and further surrounds the lower heart to cover at least the lower ventricular lower end. The jacket is secured to the heart at least surrounding the annulus and the lower ventricle. The jacket is adjustable when placed on the heart, conforms closely to the external geometry of the heart, and limits diastolic expansion of the heart beyond its maximum adjusted volume during diastole, and during systole. It can be adjusted to have a maximum adjustment volume such that the systole is performed without interruption.

Description

DETAILED DESCRIPTION OF THE INVENTION

I. Background of the Invention 1. FIELD OF THE INVENTION The present invention relates to devices and methods for treating heart disease. More particularly, the present invention relates to devices and methods for treating congestive heart disease and associated heart valve dysfunction.

[0002] 2. Prior Art Congestive heart disease is a progressive and debilitating disease. The disease is characterized by a gradual enlargement of the heart.

[0003] As the heart expands, the work done by the heart for each heartbeat to pump blood is increased. Over time, the heart expands so that it cannot supply enough blood. Patients suffering from the disease are tired, unable to perform even simple exertions, and suffer from pain and discomfort. In addition, as the heart expands, the internal heart valves do not close well. This impairs the function of the heart valve and further reduces the heart's ability to supply blood.

[0004] The causes of congestive heart disease are not completely understood. Viral infections can cause congestive heart disease. In such a case, the heart may expand so that the deleterious consequences of the heart expansion continue after the viral infection has subsided, and the course of the gradually debilitating disease continues.

[0005] Patients suffering from congestive heart disease are usually classified into four classes (ie, classes I, II, III and IV). In the early stages (eg, classes I and II), the commonly prescribed treatment is a drug treatment. Drug treatment treats the symptoms of the disease and may slow the progression of the disease. Importantly, there is no cure for congestive heart disease. The disease progresses even with drug treatment. In addition, drugs can have deleterious side effects.

Currently, heart transplants are the only maintenance therapy for congestive heart disease (perman
ent treatment). To be eligible for transplantation, the patient must be in the final stages of the disease (eg, in grades III and IV, with preference for transplantation into grade IV patients). Such patients are extremely ill. Class III patients are severely restricted in physical activity, and class IV patients show symptoms even at rest.

[0007] Because there is no effective intermediate treatment between drug treatment and heart transplantation, Class III
And IV patients experience significant suffering before being indicated for a heart transplant. Moreover, after such suffering, the treatments available are not satisfactory. Heart transplant procedures are very dangerous, extremely invasive and expensive, and only slightly extend the life of the patient. For example, the life expectancy of a Class IV patient may be six months to one year before transplantation. Heart transplantation can only extend that life to five years.

[0008] Unfortunately, not enough transplantable hearts are available to meet the needs of patients with congestive heart disease. In the United States, more than 35,000 transplant candidates compete for only about 2,000 transplant hearts a year. Transplant waiting lists are on average 8-12 months waiting, and patients often have to wait 1-2 years for the donor's heart. Historically, the availability of donor hearts has increased, but at a much slower rate. Even with the eyes closed on the risks and costs of heart transplants, this treatment option is becoming increasingly impossible. Furthermore, many patients are not considered eligible for heart transplantation because they do not meet any of the many qualification criteria.

[0009] The social impact of congestive heart failure is enormous. In the United States alone, about 50,000 people (including Class I through Class IV) suffer from the disease. Surprisingly, congestive heart failure is one of the fastest growing diseases (
Each year, 400,000 new patients in the United States). Economic cost of the disease
cost) is estimated at $ 38 billion annually.

It is not surprising that considerable efforts have been made to find alternative treatments for congestive heart disease. Recently, new surgical procedures have been developed. It is called the Batista procedure and the surgical technique involves incising and removing parts of the heart to reduce the volume of the heart. This is a completely new experimental procedure and has caused a great deal of debate. In addition, this procedure is highly invasive, dangerous and expensive, and generally includes other expensive procedures (such as concurrent heart valve replacement). Also, this treatment is given only to Class IV patients, and thus does not bring hope to patients up to Class IV who are receiving ineffective drug treatment. Finally, if this procedure fails, only emergency heart transplantation is the only possible option.

It is clear that there is a need for alternative treatments that can be applied at both the early and late stages of congestive heart disease and either stop the progression of the disease or more thoroughly slow the progression of the disease. It is. Unfortunately, the options currently under development are experimental, expensive, and problematic.

[0012] Cardiomyoplasty is a recently developed therapeutic treatment for early stage congestive heart disease (eg, dilated cardiomyopathy up to class III). In this procedure, the heart is wrapped in the latissimus dorsi (collected from the patient's shoulder) and the pace of the latissimus dorsi is constantly adjusted synchronously with ventricular contraction. As the muscle is paced, the contraction of the muscle assists the contraction of the heart during systole.

[0013] Cardiomyoplasty improves symptoms, but the nature of this improvement is not understood.
For example, one study suggests that the benefits of cardiomyoplasty are likely to come from modifications with external elastic restraints, rather than from actively assisting contractions. This study shows that the use of elastic restraints (ie, unstimulated muscle coverings placed around the heart, artificial elastic socks) can provide similar benefits. ing. Kaas et al., Cardiomyoplasty reverse degeneration in human heart failure: External elastic suppressors versus aggressive contractile assistance, 91 Circulation, 2314-2318 (1995) (Kass et al., Reverse Remodel
ing From Cardiomyoplasty In Human Heart Failure: External Constraint Ver
sus Active Assist, 91 Circulation 2314-2318 (1995)) Even if cardiomyoplasty improves symptoms, studies suggest that this procedure only slightly improves cardiac function. ing. The procedure is a highly invasive procedure that requires the extraction of the patient's muscles and a thoracotomy approach to accessing the heart (ie, sternotomy). Moreover, these procedures are expensive, and even more so are those that use paced muscles. Such procedures require expensive pacemakers. Cardiomyoplasty procedures are complex. For example, it is difficult to wrap the heart with muscles with satisfactory adhesion. Also, if sufficient blood flow to the muscle surrounding the heart is not maintained, the muscle may be necrotic. Also, after wrapping the heart, muscles may elongate and reduce their inhibitory effect, and muscles are generally difficult to adjust postoperatively. Finally, muscle forms fibrous tissue and adheres to the heart, causing an undesirable suppression of contraction of the heart during systole.

In addition to cardiomyoplasty, mechanical assist devices have been developed as an intermediate treatment for treating congestive heart disease. Examples of such devices include left ventricular assist devices (LVAD) and total artificial hearts (TAH). The LVAD includes a mechanical pump that promotes blood flow from the left ventricle to the aorta. February 26, 1991
Arnold, U.S. Pat. No. 4,995,857, of date, shows an example of such a device. LVAD surgery is still in the US clinical trial and is not generally available. Such surgery is expensive. Also, the device is subject to mechanical damage and often requires an external power supply. TAH devices, such as the well-known Jervic heart, have been used as a temporary measure while patients wait for a donor heart for transplantation.

Other attempts at cardiac assist devices include US Pat. No. 4,957,477 to Lundbaeck, September 18, 1990, and US Pat. No. 4,957,477 to Grouters, Jul. 21, 1990. 5,131,905
And Snyders, U.S. Pat. No. 5,256,132, issued Oct. 26, 1993. The Grutters and Sniders patents both teach a heart assist device that pumps fluid into a chamber opposite the heart to assist in contracting the heart during systole. The Landback patent teaches a double walled jacket surrounding the heart. Fluid fills the chamber between the two walls in the jacket. The inner wall is positioned opposite the heart and is flexible and moves with the heart. Fluid within the jacket chamber moves due to the movement of the heart during the heartbeat.

Alphanes (December 30, 1997, assigned to Common Assignee)
Alferness, U.S. Pat. No. 5,702,343, teaches a jacket that inhibits expansion of the heart during diastole. The present invention relates to U.S. Pat.
The present invention relates to an improvement of the invention disclosed in Japanese Patent No. 2,343.

II. SUMMARY OF THE INVENTION In a preferred embodiment of the present invention, methods and devices for treating congestive heart disease and related cardiac complications such as heart valve failure are disclosed. The present invention includes a jacket formed of a biocompatible material. The inner volume of the jacket is dimensioned so that the apex can be inserted and the jacket can be slid onto the heart. The jacket has a longitudinal dimension between the upper and lower ends sufficient to surround the lower heart, surrounds the annulus of the heart, and further surrounds the lower heart such that at least the lower ventricle lower end is covered. The jacket is secured to the heart at least surrounding the annulus and the lower ventricle. The jacket is placed on the heart (on the
heart) is adjustable, fits perfectly into the external geometry of the heart, and
During diastole, it can be controlled to have a maximal adjustment volume such that cardiac perimeter expansion beyond the maximum adjustment volume is suppressed and systole is performed undisturbed during systole. In one embodiment, the jacket can be secured to the patient's diaphragm after being placed around the heart.

III. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic cross-sectional view of a normal, healthy human heart during systole. FIG. 1A is a diagram of FIG. 1 showing the heart in diastole. FIG. 1B is a view of the left ventricle of a healthy heart viewed from the septum, showing the mitral valve. FIG. 2 is a schematic cross-sectional view of a human heart suffering from a disease during systole. FIG. 2A is a diagram of FIG. 2 showing the heart in diastole. FIG. 2B is a diagram of FIG. 1B showing a human heart suffering from a disease. FIG. 3 is a perspective view showing a first embodiment of the heart suppression device of the present invention. FIG. 3A is a side view of a diseased human heart with the device of FIG. 3 in place. FIG. 4 is a perspective view showing a second embodiment of the heart suppression device of the present invention. FIG. 4A is a side view of a diseased human heart with the device of FIG. 4 in place. FIG. 5 is a cross-sectional view of the device of the present invention covering the myocardium, with material of the device being brought in close contact with the heart. FIG. 6 is an enlarged view when the knit structure of the device of the present invention is in a rest state. FIG. 7 is a schematic diagram of the material of FIG.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring first to FIGS. 1 and 1A, a normal, healthy human heart H 'is shown schematically in cross section. To facilitate an understanding of the present invention, a normal, healthy human heart H 'is described herein. FIG. 1 shows the heart H ′ during systole (ie, high left ventricular pressure). FIG. 1A shows the heart H ′ during diastole (ie, low left ventricular pressure).

The heart H ′ is a muscle having an outer wall, ie, myocardium MYO ′, and an inner wall, ie, diaphragm S ′. By the myocardium MYO 'and the diaphragm S', the right atrium RA ', the left atrium LA', the right ventricle RV
', Four internal ventricles including the left ventricle LV' are defined. The heart H 'has a length measured from the upper end or base B' to the lower end or apex A 'along the longitudinal axis AA'-BB'.

The right atrium RA ′ and the left atrium LA ′ are located on the upper UP ′ of the heart H ′ adjacent to the base B ′.
It is in. The right ventricle RV 'and the left ventricle LV'
At P '. Ventricles RV 'and LV' terminate at the lower end of the ventricle LE 'close to the apex A' and are separated from the apex A 'by the thickness of the myocardium MYO'.

According to the composite curve of the upper UP ′ and the lower LP ′, the upper UP ′ and the lower LP ′
They intersect at an outer circumferential groove generally called an atrioventricular groove (AV groove) AVG '. Room RA ', RV
A number of major vessels leading to 'LA', LV 'extend from the upper UP'. For simplicity of illustration, only the superior aorta SVC 'and the left pulmonary vein LPV' are shown as representatives.

The heart H ′ is responsible for the blood flow between the chambers RA ′, RV ′, LA ′, LV ′, and the blood between these chambers and the main vessels (eg, the superior aorta SVC ′ and the left pulmonary vein LPV ′). Equipped with a flow regulating valve. Not all such valves are shown for simplicity of illustration. Instead, only the tricuspid valve TV 'between the right atrium RA' and the right ventricle RV 'and the mitral valve MV' between the left atrium LA 'and the left ventricle LV' are shown as representatives.

[0024] These valves are partially fixed to the myocardium MYO 'in the area of the lower LP', called the annulus, adjacent to the atrioventricular groove AVG '. The valves TV 'and MV' open and close with the beating cycle of the heart H '.

FIGS. 1 and 1A show normal, healthy heart H during systole and diastole, respectively.
'Is shown. During the systole (FIG. 1), the myocardium MYO 'contracts and the heart H' assumes a shape with a generally conical lower part LP '. During diastole (FIG. 1A), myocardial MYO '
Expands, and the conical shape of the lower LP ′ bulges radially outward (axis AA′-BB ′).
Against).

The movement of the heart H ′ during contraction and dilation, and the change in the shape of the heart H ′ are complicated.
Even within the heart H ', the amount of movement differs considerably. In the above operation, the axes AA'-BB '
(Conventionally referred to as longitudinal expansion or contraction). The above operation also includes a component perpendicular to the axis AA'-BB '(conventionally referred to as circumferential dilation or contraction).

Having described the healthy heart H ′ in systole (FIG. 1) and diastole (FIG. 1A), a comparison with a heart H deformed by congestive heart disease was made possible. FIG. 2 shows such a heart H in the systole and FIG. 2A shows the heart H in the diastole. Each component of the diseased heart H has the same reference numeral as a similar component in the healthy heart H ', except that an apostrophe is omitted to distinguish the diseased heart H from the healthy heart H'. ing.

Comparing FIG. 1 with FIG. 2 (showing the hearts H ′ and H in systole), the lower LP of the diseased heart H shows the tapered conical shape found in the lower LP ′ of the healthy heart H ′. You can see that it has been lost. Instead, the lower LP of the diseased heart H contains the apex A and the atrioventricular groove AVG
The space is bulging outward. Due to such deformation, the heart H (
FIG. 2) resembles a diastolic healthy heart H ′ (FIG. 1A). During diastole (FIG. 2A), the deformation becomes even more extreme.

Since the diseased heart H expands from the state shown in FIGS. 1 and 1A to the state shown in FIGS. 2 and 2A, the heart H becomes increasingly inefficient as a pump. Thus, the heart H will require more energy to pump the same amount of blood. If the disease continues, the heart H will not be able to supply sufficient blood to the patient's body and the patient will develop symptomatic dysfunction.

For simplicity of illustration, the progression of congestive heart disease will be illustrated and described with reference to progressive expansion in the lower LP of the heart H. While such expansion of the lower LP is the most common and cumbersome, expansion of the upper UP may occur.

[0031] Expansion of the heart H, in addition to cardiac dysfunction, can also cause heart valve disease. Annulus V
When the outer circumference of A becomes large, there is a possibility that the valve leaflets of the valves TV and MV separate from each other. When the heart expands to some extent, such separation may become severe and the valve leaflets may not be completely closed (illustrated by the mitral valve MV in FIG. 2A). Incomplete closure causes valve regurgitation, further deteriorating cardiac function. As mentioned earlier, valve dysfunction is caused by the enlargement of the outer circumference of the valve annulus VA, but the separation of the valve leaflets is most commonly the cause of deformation of the heart H geometry. This is best explained with reference to FIGS. 1B and 2B.

FIGS. 1B and 2B show a healthy heart and a diseased heart, respectively, with the diaphragm (
Left ventricle LV ′ in systole, as seen from FIGS. 1B and 2B),
LV is shown. In a healthy heart H ', the valve leaflets MVL' of the mitral valve MV 'are closed by left ventricular pressure. The small protruding muscles PM ', PM are connected to the heart walls MYO', MYO near the lower ventricle lower ends LE ', LE. The small protruding muscles PM ′, PM are pulling the valves MVL ′, MVL via the connecting chords CT ′, CT. Small protruding muscle PM '
The pulling of the valve leaflets MVL ', MVL by the PM functions to prevent valve leakage by maintaining the valve leaflets in a closed position during systole in a normal heart. In the heart H, in which the disease state is remarkable, the mitral valve is not sufficiently closed, and it is not possible to prevent the backflow of blood from the ventricle LV to the atrium during systole.

As shown in FIG. 1B, the geometry of a healthy heart H ′ is that the myocardium MYO ′, the small ridge muscle PM ′ and the chord CT ′ emphasize each other, and completely replace the mitral valve MV ′. It is to be closed. However, in the diseased heart H, when the myocardium MYO bulges outward (FIG. 2B), the bulge displaces the small protrusion muscle PM ′. This displacement pulls and moves the valve leaflets MVL, thereby preventing the mitral valve from completely closing.

Having described the features and problems of congestive heart disease, the treatment method and apparatus of the present invention will now be described.

Generally, the jacket of the present invention is configured to surround the myocardium MYO.
As used herein, the term "surround" means that the jacket reduces diastolic expansion of the heart wall, at least in the face of the heart, which is completely opposite to the heart, by applying a surface with a restraining force. I do. In some preferred embodiments disclosed herein, completely opposing surfaces are joined together, for example, by a continuous material that can substantially surround the outer surface of the heart.

Referring now to FIGS. 3, 3A, 4, and 4A, the device of the present invention is shown as a jacket 10 formed of a flexible biocompatible material. Jacket 10
Is an enclosed knit having upper and lower ends 12,14. The inner volumes 16, 16 'are determined by the jackets 10, 10'.
Is completely enclosed except for the open ends 12, 12 'and 14'. In the embodiment of FIG. 3, the lower end 14 is closed. In the embodiment of FIG. 4, the lower end 14 is open. In either embodiment, the upper ends 12, 12 'are open. Throughout this specification, the embodiment of FIG. 3 will be discussed. Components common to the embodiments of FIGS. 3 and 4 are denoted by the same reference numerals. Although apostrophes are used to distinguish the second embodiment, it is not necessary to separately describe these elements.

The jacket 10 is sized according to the heart to be treated. Specifically, the jacket 10 is dimensioned such that the heart H is constrained to a volume 16. The jacket 10 can be worn by sliding around the heart H. Jacket 10 has upper and lower ends 1
Between 2 and 14, there is a length L sufficient to suppress the lower LP. Jacket 10
Upper end 12 reaches at least the annulus VA, and further reaches a lower LP to suppress at least the ventricular lower end LE.

In the preferred embodiment, the jacket 10 is dimensioned such that the upper end 12 is located in the atrioventricular groove AVG, since the enlargement of the lower LP is the most troublesome. Upper UP
If it is desired to suppress the expansion of the jacket 10, the jacket 10 may be expanded so that the upper UP is covered.

For many reasons, the jacket 10 is positioned such that the upper end 12 is located in the atrioventricular groove AVG.
Is preferably sized. First, the atrioventricular groove AVG is an easily identifiable anatomical feature that assists the surgeon in placing the jacket 10. By locating the upper end 12 in the atrioventricular groove AVG, the surgeon is convinced that the jacket 10 will provide sufficient restraint against the annulus AV. The atrioventricular groove AVG and the main blood vessels act as natural stops during the installation of the jacket 10 and ensure the covering of the annulus AV. Utilizing such features as natural stops is particularly beneficial in minimally invasive surgery where the surgeon's view is obscure or limited.

When the septum pericardium is incised, there is no obstruction in the lower LP that prevents attachment of the jacket to the apex A. However, if the septum pericardium is intact, the attachment of the diaphragm to the septum pericardium prevents the apex A from wearing the jacket. In such a situation, it is possible to cut the jacket along a line from the upper end 12 'to the lower end 14'. In this way, the jacket 10 can be mounted on the pericardial surface, and the opposite ends of the incision line are joined after mounting. Systems for joining opposing ends are described, for example, in US Pat. No. 5,702,343.
And the entire disclosure of which is incorporated herein by reference. The lower end 14 'is secured to the diaphragm or associated tissue using, for example, sutures, clasps, or the like.

In the embodiment of FIGS. 3 and 3A, the lower end 14 is closed and the length L is such that the apex A of the heart H is housed in the lower end 14 when the upper end 12 is located in the atrioventricular groove AVG. Dimensioned to be In the embodiment of FIGS. 4 and 4A, the lower end 14 is open and the length L 'is such that the apex A of the heart H projects beyond the lower end 14' when the upper end 12 'is located in the atrioventricular groove AVG. It is dimensioned. Jacket 10
, 10 ′, the myocardium MYO covering the ventricles RV, LV is the jacket 1
The length L 'is dimensioned such that the lower end 14' is below the ventricular lower end LE so as to directly oppose the 0, 10 'material. Such an arrangement is equivalent to the jacket 10, 10 '
Is desirable for exhibiting an inhibitory force against the expansion of the ventricular wall of the heart H.

After placing the jacket 10 on the heart H as described above, the jacket 10 is fixed to the heart. Preferably, jacket 10 is secured to heart H with sutures. The jacket 10 is sutured to the heart H at suture positions S circumferentially spaced along the upper end 12. In order to prevent movement of the jacket 10 after installation,
Although the surgeon may select additional suturing positions, it is preferred that the number of such positions S be kept such that the contraction of the heart H during systole is not limited by the jacket 10.

The volume and shape of the jacket 10 is larger than the lower diastolic LP so that the jacket 10 can be easily placed on the heart H. With such dimensions, the jacket 10 can be easily placed by sliding around the heart H. Once installed, the volume and shape of the jacket are adjusted so that the jacket 10 closely matches the external geometry of the heart H during diastole. Such dimensional adjustment can be easily performed because the jacket 10 has a knit structure. For example, an excess portion of the material of the jacket 10 is brought together, and sewn at S ″ (FIG. 5) to reduce the volume of the jacket 10,
Match the shape of the diastolic heart H. This shape is the maximum adjustment volume. The jacket 10 prevents the heart H from expanding beyond the maximum adjustment volume, while preventing the heart H from being restricted from contracting during systole. Instead of bringing the material together as in FIG. 5, it is also possible to provide the jacket 10 with other means for adjusting the volume. For example, slots can be provided in the jacket as disclosed in U.S. Patent No. 5,702,343. The edges of the slots can be pulled together to reduce the jacket volume.

The jacket 10 is adjusted so as to be in close contact with the heart H in the diastole. Care should be taken not to overtighten the jacket 10 and impair cardiac function. During diastole, the left ventricle LV is filled with blood. If the jacket 10 is too tight, the left ventricle LV cannot be sufficiently expanded, and the left ventricular pressure increases. When adjusting the jacket 10,
The surgeon can monitor left ventricular pressure. For example, a known technique for monitoring so-called pulmonary wedge pressure uses a catheter placed in the pulmonary artery. The filling pressure at which the left atrium LA and the left ventricle LV are filled by the wedge pressure is displayed. A slight pressure increase (e.g., 2-3 mmHg) is acceptable, but the jacket 10 should be tightly fitted to the heart H with such a tightness that does not significantly increase left ventricular pressure during diastole.

As described above, the jacket 10 is made of a biocompatible knit material. The knit 18 is illustrated in FIG. The knit is preferably a so-called "Atlas Knit" which is well known in the textile industry. Regarding atlas knits, Parling's "Wrap Knitting Technology" (Columbine Press (Publisher) Ltd., Buxton, UK, 1970), page 111 (Paling, Wr .).
ap Knitting Technology , p111, Columbine Press (Publishers) Ltd., Buxton,
Great Britain (1970)).

An atlas knit is a knit of fibers 20 having directional extension properties. More specifically, although knit 18 is generally formed of inelastic fibers 20, knit 18 allows for the construction of a stretchable woven fabric that is at least slightly more stretchable than at rest. FIG. 6 shows the knit in the rest state. The fibers 20 of the woven fabric 18 are woven to form two sets of fiber strands 21a, 21b having longitudinal axes _Xa and _Xb . The strands 21a and 21b are interwoven to form a woven fabric 18 having strands 21a that are usually parallel and spaced apart from each other and strands 21b that are usually parallel and spaced apart from each other.

For simplicity of illustration, the woven fabric 18 is schematically shown in FIG. 7 with only the axes of the strands 21 a and 21 b shown. Strands 21a, a 21b, interlinked woven in the axial X _a and X _b, to form an open cell of diamond shape having a diagonal axis A _m. In a preferred embodiment, it is 5mm length of the axis A _m when the fabric 18 is not stretched there dormant. The woven fabric 18 is stretched when a force is applied.
Relates any given force, the fabric 18 is best extend when parallel force is applied to swash axis A _m. The woven fabric 18 does not stretch the most when a force is applied parallel to the strand axes _Xa and _Xb . Jacket 10 has knitted materials, oblique A _m is configured to be arranged in a direction as to be parallel to the longitudinal axis AA-BB of the heart.

Although the jacket 10 can be stretched by the above-described knit pattern, it is preferable that the fiber 20 itself of the knit 18 does not stretch. Preferably, the fibers 20 are formed of a material having a low modulus of elasticity, although any material will stretch at least slightly. The fibers 20 are inelastic, corresponding to the low pressure of the heart H during diastole. In a preferred embodiment, the fibers are 70 denier polyester. Polyester is currently preferred, but examples of other suitable materials include polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePT).
FE), polypropylene and stainless steel.

[0049] Knit materials have a number of advantages. Such a material is flexible and allows for unrestricted movement of the heart H (except for the desired suppression of peripheral dilatation). The material may be provided with apertures, thereby defining a plurality of interstitial cavities for fluid permeation and minimizing the amount of surface area where the heart H and jacket 10 are in direct contact (this reduces the sensitivity or abrasion site). Can be minimized), and fibrosis and scar tissue can be minimized.

The open area of the knitted structure also allows electrical connection between the heart and surrounding tissue, and allows current to flow to and from the heart. For example, knit material is an electrical insulator,
The knitted structure with openings has sufficient electrical permeability to allow the use of a cardiac defibrillator. In addition, the elastic structure having the opening allows a passage for an electric element (for example, a lead wire of a pacemaker) to be formed in the jacket. In addition, the apertured structure allows other procedures, such as coronary artery bypass, to be performed without removing the jacket.

In order to minimize the amount of surface area of the heart H in direct contact with the material of the jacket 10 (thus reducing fibrosis), it is desirable for the cell 23 to have a large open area. However, if the area of the cell 23 is too large, a local aneurysm will be formed. Also, the strands 21a, 21b cover the coronary artery with sufficient force to partially block the coronary artery. Small cell size increases the number of strands, which reduces the limiting force per strand. Preferably, the cell has a maximum area of no more than 6.45 cm ² (about 2.54 cm × 2.54 cm), and more preferably no more than 0.25 cm ² (about 0.5 cm × 0.5 cm). The maximum area of the cell refers to the area of the cell 23 after the material of the jacket 10 has been completely stretched and adjusted to the maximum adjusted volume on the heart H as described above.

The woven fabric 18 preferably has tear resistance and fray resistance. Even in the case where the material is defective or inadvertently torn, the knit structure limits the transmission of such defects and tears.

With the above, apparatus and methods for treating heart disease have been taught. The jacket 10 suppresses further undesired perimeter enlargement of the heart, while not limiting other movements of the heart. Numerous changes can be made while retaining the benefits currently taught. For example, the jacket 10 need not be directly attached to the epicardium (ie, the outer surface of the myocardium), but can be placed on the parietal pericardium. Further, an antifibrotic lining (such as a PTFE coating on knitted fibers) may be placed between the heart H and the jacket 10. Alternatively, the fibers 20 may be coated with PTFE.

The jacket 10 is inexpensive, easy to install and secure, and easy to use for minimally invasive procedures. The thin elastic woven fabric 18 can be folded and passed through a small diameter tube in a minimally invasive procedure.

The jacket 10 can be used at an early stage of congestive heart disease. For patients who are experiencing heart enlargement due to a viral infection, jacket 10 suppresses heart H for a time sufficient for the viral infection to subside. In addition to preventing further heart enlargement,
The jacket 10 can treat the expansion of the outer circumference of the annulus and deformation of the ventricle wall.

The jacket 10, including its knit structure, has a heart H in the longitudinal and circumferential directions.
Does not interfere with the contraction of the heart (necessary for cardiac function). Unlike a solid wrap (such as a muscular wrap in a cardiomyoplasty procedure), the fabric 18 does not prevent the heart from contracting. After sizing, the jacket 10 is inelastic to prevent further heart enlargement, but does not limit inward movement of the ventricular wall. Jacket 1 with cell structure with openings
Access to the coronary arteries is made possible in a bypass procedure performed after the placement of the zero. Also, in cardiomyoplasty, the thickness of the latissimus dorsi is not constant and is thick (range of about 1 mm to 1 cm). On the other hand, the material of the jacket 10 is equally thin (1
mm or less). According to this thin-wall structure, fibrosis is less likely to occur, and interference with the contractile function of the heart can be minimized.

Studies of this device through animal experiments have shown the efficacy of the present invention. Experimental animals were equipped with the jacket 10 of FIG. The animal's heart was rapidly paced to induce expansion. After 6 weeks, animals without the device had significant cardiac expansion, whereas animals with the device did not. In addition, mitral regurgitation was significantly reduced in animals with the device.

In addition to the above, the present invention can be used not only to prevent further heart enlargement, but also to reduce the size of the heart during installation. For example, the device can be placed on the heart and the device can be sized to fit the heart to a reduced size. More preferably, the size of the heart is reduced by a drug (eg, dobutamine, dopamine, or epineline, or other positive inotropic agent) when the jacket is placed. The jacket of the present invention is then placed snugly over the reduced heart to prevent the heart from expanding beyond its reduced size.

With the above, inexpensive and reduced risk methods and devices for treating heart disease have been taught. The present invention is applicable to both early stage and late stage patients with congestive heart disease. The present invention reduces heart dilatation as well as heart valve regurgitation.

[Brief description of the drawings]

FIG. 1 is a schematic cross-sectional view of a normal, healthy human heart during systole. FIG. 1A
FIG. 2 is a diagram of FIG. 1 showing the heart in diastole. FIG. 1B is a view of the left ventricle of a healthy heart viewed from the septum, showing the mitral valve.

FIG. 2 is a schematic cross-sectional view of a human heart suffering from a disease during systole. FIG. 2A
FIG. 3 is a diagram of FIG. 2 showing the heart in diastole. FIG. 2B is a diagram of FIG. 1B showing a human heart suffering from a disease.

FIG. 3 to FIG. 3A are perspective views showing a first embodiment of the heart suppression device of the present invention. FIG. 3A
Figure 4 is a side view of a human heart suffering from a disease with the device of Figure 3 in place.

FIG. 4 to FIG. 4A are perspective views showing a second embodiment of the heart suppression device of the present invention. FIG. 4A
5 is a side view of a human heart suffering from a disease with the device of FIG. 4 in place.

FIG. 5 is a cross-sectional view of the device of the present invention covering the myocardium, with the material of the device being brought into close conformity with the heart.

FIG. 6 is an enlarged view when the knit structure of the device of the present invention is in a rest state.

FIG. 7 is a schematic diagram of the material of FIG. 6;

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] August 3, 2000 (2008.3.3)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR , BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS , JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Raman, J, S. Australia, 3104 Victoria, North Baldwin, The Boulevard 30 (72) Inventor Power, John, M. 65, Hanan Street, Williamstown, Victoria, 3016 Victoria, Australia (72) Inventor Sabbar, Hani, NJ. 1141 F-term, Meadwood, Waterford, Washington, USA, 43127 F-term (reference) 4C084 AA17 ZA362 ZC412 4C097 AA26 BB01 CC01 DD02 DD04 EE02 EE06 FF11

Claims (20)

[Claims] 1. A valve having a longitudinal axis extending from the apex to the base of the heart, an upper portion and a lower portion separated by an atrioventricular groove, and having an annulus adjacent to the atrioventricular groove and a lower end of the ventricle adjacent to the apex. Apparatus for treating a heart disease in a broken heart, comprising a jacket formed of a flexible material having a knitted structure and having a volume between an open upper end and a lower end, wherein the jacket has the open upper end. Through which the apex is inserted and is dimensioned so that the jacket can be slid onto the heart, and the longitudinal dimension between the upper end and the lower end of the jacket is such that the jacket is Restraining the annulus, and further dimensioned to be sufficient to restrain the lower portion in a restrained manner with the ventricular lower end, wherein the jacket is between the valve annulus and the ventricular lower end. Previous Secured to the heart to have diametrically positioned portions on the heart, the jacket closely conforming to the external geometry of the heart over the heart and maximally adjusting during diastole A device that inhibits circumferential expansion of the heart beyond its volume and is adjusted to have a maximum adjusted volume such that during systole contraction occurs substantially undisturbed. 2. The expansion of the material along the first axis by a force applied parallel to the first material axis, the second axis being caused by the same force applied parallel to the second axis. 3. The apparatus of claim 2, wherein the material is oriented such that the first axis extends in a circumferential direction of the longitudinal dimension greater than an extension of the material along the axis. 3. The apparatus of claim 1, wherein said jacket is open at said lower end. 4. The apparatus of claim 1, wherein said jacket is closed at said lower end. 5. The device of claim 1, wherein said material is fray resistant. 6. The expansion of the material along the first axis by a force applied parallel to a first material axis, wherein the expansion of the material along the first axis is caused by the same force applied parallel to a perpendicular second axis. The apparatus of claim 5, wherein the material is oriented such that the first axis extends from the upper end of the jacket toward the lower end of the jacket, the extension being greater than the extension of the material along two axes. 7. After the jacket has been placed on the heart, the material has sufficient flexibility to drive the excess of the material so that the material closely matches the external geometry of the heart. The device of claim 1 comprising: 8. After the jacket has been placed on the heart, the material has sufficient flexibility to drive the excess of the material so that the material closely matches the external geometry of the heart. An apparatus according to claim 5, comprising: 9. The apparatus according to claim 1, wherein said material is selected from the group consisting of polytetrafluoroethylene, expanded polytetrafluoroethylene, polypropylene or stainless steel. 10. The apparatus of claim 5, wherein said material is formed of an expanded fiber selected from the group consisting of polytetrafluoroethylene, expanded polytetrafluoroethylene, polypropylene, or stainless steel. 11. The apparatus of claim 1, wherein the jacket is sized to at least partially cover and constrain the top. 12. The apparatus of claim 1, further comprising a lining formed of an antifibrotic material, sized and positioned to be provided between the heart and the jacket.
An apparatus according to claim 1. 13. The apparatus of claim 1, wherein said jacket is electrically permeable. 14. A vertical axis extending from the apex to the base of the heart, an upper portion and a lower portion delimited by an atrioventricular groove, comprising an annulus adjacent to the atrioventricular groove and a lower end of the ventricle adjacent to the apex. A device for treating a heart disease of a heart, wherein the device is formed of a flexible, electrically permeable material and disposed between the valve annulus and the lower end of the ventricle at diametrically opposite positions in the heart. A jacket secured to the heart such that the jacket closely conforms to the external geometry of the heart over the heart, and provides a diastolic expansion of the heart that exceeds the maximum adjusted volume. A device that is arrested and adjusted to have a maximum adjusted volume such that systole occurs undisturbed during systole. 15. The device of claim 2, wherein the jacket surrounds the outer periphery of the heart. 16. A method for treating a disease of a patient's heart, comprising: surgically accessing a patient's heart and diaphragm; and surrounding the heart, a biomedical material having an upper end and a lower end. Disposing a jacket that includes the jacket over the heart to closely conform to the external geometry of the heart and to restrict peripheral dilation of the heart beyond diastolic volume during diastole, A method comprising: adjusting to have a maximum adjustment volume such that cardiac contraction is performed without interruption during a period; and securing a lower end of the jacket to the diaphragm. 17. The method of claim 16, wherein the lower end of the jacket is secured to the diaphragm using a suture. 18. A valve having a longitudinal axis extending from the apex to the base of the heart, an upper portion and a lower portion separated by an atrioventricular groove, and having an annulus adjacent to the atrioventricular groove and a lower end of the ventricle adjacent to the apex. A method for treating a heart disease in a heart, comprising: surgically accessing a patient's heart; applying a medication to the heart to reduce the size of the heart; Placing the jacket on the heart such that the jacket has portions located at diametrically opposite positions in the heart between the annulus and the lower end of the ventricle; and After that, the jacket fits closely on the external geometry of the heart on the heart, and inhibits the diastolic expansion of the heart beyond the maximum adjustment volume during diastole, and during systole Hindered Without and adjusting to have a maximum adjustment volume as cardiac contraction is performed, the remains of the jacket was placed in position of the heart, the method including the surgical closure access to the heart. 19. The method of claim 18, further comprising placing the jacket over the top, and securing the jacket over the top. 20. The method of claim 18, wherein said drug treatment comprises administration of a positive inotropic agent to the patient.